Responsibilities will include, but are not limited to, the following:

The Scientist I should work with minimal supervision to carry out laboratory based de novo analytical methods development, chemical characterization studies and chemical stability characterization evaluations. Where required, activities will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures.
 Support drug substance process development including characterization of starting materials, intermediates and final API.
 Support drug product formulation and process development including characterization of the process and finished product.
 Develop, optimize and validate analytical methods.
 Support drug substance and drug product impurity characterization and identification.
 Generate laboratory clinical release and stability data.
 Qualify/transfer analytical methodology to quality control and contract laboratories.
 Provide leadership and supervision to scientific staff.
 Develop, coach and mentor others.
 Serve on and lead departmental, interdepartmental and project teams.
 Report and discuss analytical results and conclusions both orally and in writing.
 Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
 Review analytical data for completeness and correctness.
 Adhere to all relevant compliance requirements.

Qualifications
Skills/Knowledge Required:
 Academic background in Analytical Chemistry or an allied chemistry discipline (e.g. Physical, Organic) with demonstrated analytical capabilities.
 Comprehensive knowledge of chemistry with extensive expertise in measurement science.
 A demonstrated record of scientific accomplishment, laboratory experimentation, publication and presentation.
 Extensive laboratory experience with and an in-depth knowledge of conventional laboratory characterization techniques such as HPLC, GC, UV, IR, mass spectrometry, and NMR is a must.
 Fluency in synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing or pharmaceutical sciences is expected.
 Strong problem-solving and troubleshooting skills.
 Strong capabilities in experimental design and execution.
 Ability to work independently.
 Ability to provide scientific guidance, leadership and training to others within the department.
 Ability to manage others and a commitment to and demonstrated proficiency in employee development.
 Strong verbal and written communication skills.
 Strong interpersonal skills and the ability and interest to serve as a team member/leader in an environment where individual initiative, collaboration and accountability are valued.
 Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidances.
 Familiarity with the USP and other compendia.

Skills/Knowledge in one or more of the following areas are a plus:
 Advanced skills in statistics and statistical analysis of process capability.
 Advanced skills in DOE, Lean and/or Six Sigma.
 Knowledge of dissolution method development and testing, biopharmaceutical classification system, and IVIVC / IVIVR.
 Modern laboratory automation.